FDA recall Z-0147-2026

Ethicon Endo-Surgery Inc · Class II · device

Product

ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

Reason for recall

The devices were shipped unsterilized.

Distribution

International distribution to the countries of United Arab Emirates.

Key facts

Status
Ongoing
Initiation date
2025-09-11
Report date
2025-10-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Blue Ash, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0147-2026